Urinary tract infections (UTIs) are believed to be induced most frequently by direct inoculation of the urethra with gastrointestinal flora during sexual intercourse. The four leading risk factors for acute UTI are female sex, recent sexual intercourse, previous UTI, a new sexual partner, and history of urinary tract infection in a first-degree female relative. Anatomical considerations are believed to play a role in UTI heritability as shorter urethras and shorter distances between the urethra and the anus, provide less protection against cystitis compared to longer urethras.
Urinary tract infections are extremely common. UTI incidence was 0.70 episodes per person per year in a study of college women starting a new contraceptive method. Among young, healthy women with UTI, the infection recurs in 25% of women within 6 months. Urinary tract infections are also debilitating. Typical symptoms include urinary frequency, abdominal pain, fever, chills, and back pain. If untreated, symptoms can persist for 5-6 days and on average, women are bedridden for half of one day per UTI. Urinary tract infections also have considerable economic consequences.
3.5 billion USD is spent annually on UTI care including 8.6 million office visits in 2007 for UTIs in the U.S. alone. On average, one day of work or school is missed per UTI. Recurrent UTI is defined as a UTI within six months of a prior UTI. Approximately 7.5 million adult American women experience two or more UTIs per year. The current standard of care reflects the numerous challenges and unmet needs in the field. Acutely, symptoms are managed with broad-spectrum antimicrobials (such as fluoroquinolones). Following symptomatic improvement, nonantimicrobial strategies are implemented to prevent recurrence. These include urination soon after intercourse, liberal fluid intake, wiping front to back following defecation, and avoidance of tightfitting underwear. Cranberry products and D-mannose are often recommended despite very limited evidence that these interventions are efficacious and some evidence to suggest that the cranberry related treatments are actually damaging. If non-antimicrobial measures fail to prevent additional urinary tract infections, clinicians will often try systemic antimicrobial prophylaxis. Either post-coital or daily bedtime antimicrobial prophylaxis is prescribed (usually Bactrim or nitrofurantoinare selected) with systemic exposure to the antimicrobial occurring for months if not years. This approach contributes to bacterial resistance and can induce noxious drug side effects.
Previous efforts to develop tools for urinary tract infection prophylaxis have focused on vaccine development. However, commercially available vaccines such as Uro-Vaxom and Solco Urovac have limited efficacy data, are expensive, and require frequent booster shots.
Given that the etiology of urinary tract infection is related to direct inoculation of the female urethra with gastrointestinal flora, it would be desirable to have a barrier that may have antimicrobial characteristics and be adhesive in nature when engaged with a person and that could be applied at the time of sexual intercourse that covered the urethral orifice, preventing bacterial access to the urethra, and could be removed after sexual intercourse
A need therefore exists for a method or solution that addresses these disadvantages.